BEUDAMED
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    Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73. Product Usage: The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular, ejection, fraction, and end diastolic volume.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DXG·September 12, 2008

    Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DQK·October 2, 2017

    Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·February 7, 2018

    Arthrocare 3.0mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5030, Axya Medical, Inc., Beverly, MA 01915

    FDA Recall
    Terminated ·Axya Medical·Product code MBI·September 27, 2007

    Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5055 , Axya Medical, Inc., Beverly, MA 01915

    FDA Recall
    Terminated ·Axya Medical·Product code MBI·September 27, 2007

    Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065, Axya Medical, Inc., Beverly, MA 01915

    FDA Recall
    Terminated ·Axya Medical·Product code MBI·September 27, 2007

    Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number: 22-5055N, Axya Medical, Inc., Beverly, MA 01915

    FDA Recall
    Terminated ·Axya Medical·Product code MBI·September 27, 2007

    Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number:22-5065N, Axya Medical, Inc., Beverly, MA 01915

    FDA Recall
    Terminated ·Axya Medical·Product code MBI·September 27, 2007

    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·August 31, 2016

    Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) DRAPE BEACH CHAIR SHOULDER UF (1) CO BAN WRAP 4"X5 YRD LATEX (1) GOWN IMP. XTRA REINF. X-LGE UF (1) TUR Y SET 81" 2.1M REG. CLAM (1) GOWN IMP. POL YREINF XLGE T/WRAP UF (1) TABLE COVER REINF. 50" X 90" UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    EasyRA Cuvette Segment 1, P/N 007000-001 (In Vitro Diagnostic ) EasyRA Cuvette Segments included in the following Kits: EasyRA Cuvettes, REF 10700-4 Startup Kit - Chemistry, REF 10990 Startup Kit - Chemistry & ISE, REF 10991

    FDA Recall
    Terminated ·Medica Corporation·Product code JJE·March 29, 2010

    Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) DRAPE BEACH CHAIR SHOULDER UF (1) CO BAN WRAP 4"X5 YRD LATEX (1) GOWN IMP. XTRA REINF. X-LGE UF (1) TUR Y SET 81" 2.1M REG. CLAM (1) GOWN IMP. POL YREINF XLGE T/WRAP UF (1) TABLE COVER REINF. 50" X 90" UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FKX·October 7, 2013

    Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels also include a sterilization indication dot. This system is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplasty

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KWS·April 26, 2017

    The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code IEO·August 5, 2015

    Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Recall
    Terminated ·Product code ECO·May 1, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Recall
    Terminated ·Product code ECO·May 1, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Recall
    Terminated ·Product code ECO·May 1, 2018

    Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code IDO·August 12, 2011

    ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH, Heidelberger Str. 17-19, D-69226 Nussloch, Germany; The intended use of this device is as an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code IEO·March 30, 2012